NCT00154492

Brief Summary

This trial is conducted in Asia and Europe. The trial is planned to investigate the effectiveness and safety of NovoSeven® in patients with advanced cirrhosis and active variceal bleeding.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2004

Geographic Reach
12 countries

44 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

2.3 years

First QC Date

September 9, 2005

Last Update Submit

January 12, 2017

Conditions

Acquired Bleeding DisorderCirrhosis

Keywords

Active variceal bleeding in patients with advanced cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Treatment failure

    Within 5 days after first trial product administration

Secondary Outcomes (3)

  • Mortality

  • Rebleeding

  • Control of acute bleeding

Interventions

activated recombinant human factor VIIDRUG

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Variceal bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (44)

Novo Nordisk Investigational Site

Vienna, A 1090, Austria

Location

Novo Nordisk Investigational Site

Olomouc, 77520, Czechia

Location

Novo Nordisk Investigational Site

Prague, 12821, Czechia

Location

Novo Nordisk Investigational Site

Prague, 140 21, Czechia

Location

Novo Nordisk Investigational Site

Aarhus, 8000, Denmark

Location

Novo Nordisk Investigational Site

Helsinki, 00029 HUS, Finland

Location

Novo Nordisk Investigational Site

Angers, 49033, France

Location

Novo Nordisk Investigational Site

Caen, 14033, France

Location

Novo Nordisk Investigational Site

Clichy, 92 188, France

Location

Novo Nordisk Investigational Site

Grenoble, 38043, France

Location

Novo Nordisk Investigational Site

Lille, 59037, France

Location

Novo Nordisk Investigational Site

Limoges, 87042, France

Location

Novo Nordisk Investigational Site

Marseille, 13385, France

Location

Novo Nordisk Investigational Site

Nantes, 44093, France

Location

Novo Nordisk Investigational Site

Nice, 06202, France

Location

Novo Nordisk Investigational Site

Paris, 75012, France

Location

Novo Nordisk Investigational Site

Paris, 75013, France

Location

Novo Nordisk Investigational Site

Toulouse, 31059, France

Location

Novo Nordisk Investigational Site

Villejuif, 94804, France

Location

Novo Nordisk Investigational Site

Berlin, 13353, Germany

Location

Novo Nordisk Investigational Site

Heidelberg, 69120, Germany

Location

Novo Nordisk Investigational Site

Leipzig, 04103, Germany

Location

Novo Nordisk Investigational Site

München, 81377, Germany

Location

Novo Nordisk Investigational Site

Münster, 48145, Germany

Location

Novo Nordisk Investigational Site

Ulm, 89081, Germany

Location

Novo Nordisk Investigational Site

Shatin, 32, Hong Kong

Location

Novo Nordisk Investigational Site

Milan, 20162, Italy

Location

Novo Nordisk Investigational Site

Napoli, 80131, Italy

Location

Novo Nordisk Investigational Site

Palermo, 30146, Italy

Location

Novo Nordisk Investigational Site

Katowice, 40-752, Poland

Location

Novo Nordisk Investigational Site

Krakow, 31-826, Poland

Location

Novo Nordisk Investigational Site

Warsaw, 02-097, Poland

Location

Novo Nordisk Investigational Site

Badalona, 08916, Spain

Location

Novo Nordisk Investigational Site

Barcelona, 08003, Spain

Location

Novo Nordisk Investigational Site

Barcelona, 08025, Spain

Location

Novo Nordisk Investigational Site

Barcelona, 08036, Spain

Location

Novo Nordisk Investigational Site

Córdoba, 14004, Spain

Location

Novo Nordisk Investigational Site

Madrid, 28007, Spain

Location

Novo Nordisk Investigational Site

Madrid, 28034, Spain

Location

Novo Nordisk Investigational Site

Majadahonda, 28222, Spain

Location

Novo Nordisk Investigational Site

Taipei, 112, Taiwan

Location

Novo Nordisk Investigational Site

Leeds, LS9 7TF, United Kingdom

Location

Novo Nordisk Investigational Site

London, WC1 6HX, United Kingdom

Location

Novo Nordisk Investigational Site

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (1)

  • Hsia CC, Chin-Yee IH, McAlister VC. Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec.

    PMID: 18580208RESULT

Related Links

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 12, 2005

Study Start

April 1, 2004

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

January 13, 2017

Record last verified: 2017-01

Locations

IT(3)FI(1)HK(1)GB(3)ES(8)FR(13)DK(1)AU(1)DE(6)CZ(3)PL(3)TW(1)